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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions including anaphylaxis and serious skin reactions: if an allergic reaction occurs discontinue the drug. ( 5.1 ) Severe cases of hemolytic anemia, including fatalities, have been reported. If patient develops anemia, discontinue drug. ( 5.2 ) Fall in prothrombin activity and risk of bleeding may occur. Monitor prothrombin time and administer exogenous vitamin K as indicated ( 5.3 ) Clostridium difficile -associated diarrhea. May range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. ( 5.4 ) 5.1 Hypersensitivity Reactions to Cefotetan, or Other Beta-lactam Antibacterial Drugs Serious and occasionally fatal hypersensitivity reactions (e.g., anaphylaxis) have been reported in patients on beta-lactam antibacterials, including cefotetan [see Adverse Reactions (6.1) ] . These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Cefotetan for Injection and Dextrose Injection is contraindicated in patients with a known hypersensitivity to cefotetan or other beta-lactam antibacterial drugs [see Contraindications (4) ] . Before initiating therapy with Cefotetan for Injection and Dextrose Injection, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. Cross-hypersensitivity among beta-lactam antibacterial drugs has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue Cefotetan for Injection and Dextrose Injection and institute appropriate therapy. 5.2 Hemolytic Anemia An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials. Severe cases of hemolytic anemia, including fatalities, have been reported in association with the administration of Cefotetan for Injection and Dextrose Injection. There appears to be an increased risk of developing hemolytic anemia on Cefotetan for Injection and Dextrose Injection relative to other cephalosporins of at least 3 fold. If a patient develops anemia anytime within 2–3 weeks subsequent to the administration of Cefotetan for Injection and Dextrose Injection, the diagnosis of a cephalosporin associated anemia should be considered and the drug stopped until the etiology is determined with certainty. Blood transfusions may be considered as needed [see Contraindications (4.2) ]. Patients who receive courses of Cefotetan for Injection and Dextrose Injection for the treatment or prophylaxis of infections should have periodic monitoring for signs and symptoms of hemolytic anemia including a measurement of hematological parameters where appropriate. 5.3 Prothrombin Activity and Risk of Bleeding Cefotetan for Injection and Dextrose Injection may be associated with a fall in prothrombin activity and, possibly, subsequent bleeding. Those at increased risk include patients with renal or hepatobiliary impairment or poor nutritional state, the elderly, and patients with cancer. Prothrombin time should be monitored and exogenous vitamin K administered as indicated. 5.4 Clostridium difficile -associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefotetan for Injection and Dextrose Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. 5.5 Risk of Development of Drug-resistant Bacteria Prescribing Cefotetan for Injection and Dextrose Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Prolonged use of Cefotetan for Injection and Dextrose Injection may result in overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection does occur during therapy, appropriate measures should be taken. 5.6 Drug/Laboratory Test Interactions Urinary Glucose The administration of Cefotetan for Injection and Dextrose Injection may result in a false positive reaction for glucose in the urine when using glucose tests based on Benedict’s copper reduction reaction that determine the amount of reducing substances like glucose in the urine. It is recommended that glucose tests based on enzymatic glucose oxidase be used. Serum and Urine Creatinine As with other cephalosporins, high concentrations of cefotetan may interfere with measurement of serum and urine creatinine levels by Jaffé reaction and produce false increases in the levels of creatinine reported. 5.7 Patients with a History of Gastrointestinal Disease Cefotetan for Injection and Dextrose Injection is not recommended in individuals with a history of gastrointestinal disease, particularly colitis. 5.8 Patients with Overt or Known Subclinical Diabetes Mellitus or Carbohydrate Intolerance Cefotetan for Injection and Dextrose Injection should be monitored in patients if Cefotetan for Injection and Dextrose Injection is prescribed in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason.
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Hypersensitivity reactions to Cefotetan, Cephalosporins, Penicillins, or Other Beta-lactam Antibacterial Drugs [see Warnings and Precautions (5.1) ] • Hemolytic Anemia [see Warnings and Precautions (5.2) ] • Prothrombin Activity and Risk of Bleeding [see Warnings and Precautions (5.3) ] • Clostridium difficile -associated diarrhea [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence > 1%): Gastrointestinal, including diarrhea. Hematologic abnormalities. Hepatic enzyme elevations. Hypersensitivity reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-800-854-6851 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, the following adverse reactions were considered related to Cefotetan for Injection and Dextrose Injection therapy. Table 3: Adverse Reactions (≥1%) in Clinical Studies of Cefotetan Adverse Reaction Cefotetan (%) Gastrointestinal disorders Diarrhea 1.25% Hematologic disorders Laboratory abnormalities 1.4% Hepatic enzyme elevations 1.2% Immune System disorders Hypersensitivity reactions 1.2% Table 4: Adverse Reactions (<1%) in Clinical Studies of Cefotetan Adverse Reaction Cefotetan (%) Gastrointestinal disorders Nausea 0.14% Hematologic disorders Eosinophilia 0.5% Positive direct Coombs’ test 0.4% Thrombocytosis 0.3% Hepatic enzyme elevations Elevation in ALT (SGPT) 0.7% Elevation in AST (SGOT) 0.3% Elevation in alkaline phosphatase 0.14% Elevation in LDH 0.14 % Immune System disorders Rash 0.7% Itching 0.14% Local Reactions Phlebitis at site of injection 0.3% Discomfort 0.2% 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of Cefotetan for Injection and Dextrose Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to readily estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal: pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment or surgical prophylaxis. [see Warnings and Precautions (5.4) ]. Hematologic: agranulocytosis, hemolytic anemia, leukopenia, thrombocytopenia, and prolonged prothrombin time with or without bleeding. Hypersensitivity: anaphylactic reactions and urticaria. Renal: Elevations in BUN and serum creatinine have been reported. Urogenital: Nephrotoxicity has been reported. Miscellaneous: Fever 6.3 Cephalosporin-class Adverse Reactions In addition to the adverse reactions listed above which have been observed in patients treated with cefotetan, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibacterials: pruritus, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, vomiting, abdominal pain, colitis, superinfection, vaginitis including vaginal candidiasis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, elevated bilirubin, pancytopenia, and neutropenia. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced. [see Dosage and Administration (2) and Overdosage (10) ]. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.